1. Field of the Invention
The present invention relates to medical catheters used in treating saphenous vein grafts, coronary arteries, and other blood vessels, and more particularly, to a method for exchanging catheters during emboli containment in such vessels.
2. Description of the Related Art
Guidewires are conventionally used to guide the insertion of various medical instruments, such as catheters, to a desired treatment location within a patient""s vasculature. In a typical procedure, the clinician forms an access point for the guidewire by creating an opening in a peripheral blood vessel, such as the femoral artery. The highly flexible guidewire is then introduced through the opening into the peripheral blood vessel, and is then advanced by the clinician through the patient""s blood vessels until the guidewire extends across the vessel segment to be treated. Various treatment catheters, such as a balloon dilatation catheter for a percutaneous transluminal coronary angioplasty, may then be inserted over the guidewire and similarly advanced through vasculature until they reach the treatment site.
In certain treatment procedures, it is desirable to successively introduce and then remove a number of different treatment catheters over a guidewire that has been placed in a particular location. In other words, one treatment catheter is xe2x80x9cexchangedxe2x80x9d for another over a single guidewire. Such an exchange typically involves withdrawing the treatment catheter over the guidewire until the treatment catheter is fully removed from the patient and the portion of the guidewire which extends from the patient. The guidewire is then available to act as a guide for a different treatment catheter.
As can be readily appreciated, the withdrawal of treatment catheters over a placed guidewire may result in the guidewire being displaced from its position. To overcome this difficulty, the prior art has developed xe2x80x9canchorablexe2x80x9d guidewires, which generally feature some structure on their distal ends to releasably secure the guidewire at a particular location in the patient for the duration of the medical procedure. One such anchorable guidewire is disclosed in U.S. Pat. No. 5,167,239 to Cohen et al., which discloses a hollow guidewire with an inflation lumen and an expandable balloon on its end. The Cohen device includes a removable inflation manifold, and a check valve to maintain the balloon in the inflated state when the manifold is removed. The check valve apparatus used by the Cohen device is relatively bulky, and is described as having an outer diameter in its preferred embodiment of 0.0355 inches. Consequently, any treatment catheter intended to be inserted over the Cohen device must have an interior guidewire lumen larger than the outer diameter of the Cohen valve, which for the preferred embodiment, requires an interior lumen with a diameter of more than 0.0355 inches. Cohen also does not address the problem of emboli containment.
As is readily appreciated by those of skill in the art, increasing the interior lumen size of a treatment catheter results in an increase in the outer diameter of the treatment catheter. However, many blood vessels where it is desirable to apply catheter treatment are quite narrow. For example, the left coronary arteries are blood vessels having diameters ranging from 2 to 4 mm, and are susceptible to plaque. Similarly, saphenous vein grafts (SVG) and the carotid arteries are also quite small and susceptible to plaque, and could not practically be treated by larger diameter devices.
Human blood vessels often become occluded or completely blocked by plaque, thrombi, other deposits, emboli or other substances, which reduce the blood carrying capacity of the vessel. Should the blockage occur at a critical place in the circulatory system, serious and permanent injury, or even death, can occur. To prevent this, some form of medical intervention is usually performed when significant occlusion is detected.
Coronary heart disease is an extremely common disorder in developed countries, and is the leading cause of death in the U.S. Damage to or malfunction of the heart is caused by narrowing or blockage of the coronary arteries (atherosclerosis) that supply blood to the heart. The coronary arteries are first narrowed and may eventually be completely blocked by plaque, and may further be complicated by the formation of thrombi (blood clots) on the roughened surfaces of the plaques. Myocardial infarction can result from atherosclerosis, especially from an occlusive or near occlusive thrombi overlying or adjacent to the atherosclerotic plaque, leading to death of portions of the heart muscle. Thrombi and emboli also often result from myocardial infarction, and these clots can block the coronary arteries, or can migrate further downstream, causing additional complications.
Various types of intervention techniques have been developed which facilitate the reduction or removal of the blockage in the blood vessel, allowing increased blood flow through the vessel. One technique for treating stenosis or occlusion of a blood vessel is balloon angioplasty. A balloon catheter is inserted into the narrowed or blocked area, and the balloon is inflated to expand the constricted area. In many cases, near normal blood flow is restored. It can be difficult, however, to treat plaque deposits and thrombi in the coronary arteries, because the coronary arteries are small, which makes accessing them with commonly used catheters difficult.
Other types of intervention include atherectomy, deployment of stents, introduction of specific medication by infusion, and bypass surgery. Each of these methods are not without the risk of embolism caused by the dislodgement of the blocking material which then moves downstream. In addition, the size of the blocked vessel may limit percutaneous access to the vessel.
In coronary bypass surgery, a more costly and invasive form of intervention, a section of a vein, usually the saphenous vein taken from the leg, is used to form a connection between the aorta and the coronary artery distal to the obstruction. Over time, however, the saphenous vein graft may itself become diseased, stenosed, or occluded, similar to the bypassed vessel. Atherosclerotic plaque in saphenous vein grafts tends to be more friable and less fibrocalcific than its counterpart in native coronary arteries.
Diffusely diseased old saphenous vein grafts with friable atherosclerotic lesions and thrombi have therefore been associated with iatrogenic distal embolic debris. Balloon dilatation of saphenous vein grafts is more likely to produce symptomatic embolization than dilatation of the coronary arteries, not only because of the difference in the plaque but also because vein grafts and their atheromatous plaques are generally larger than the coronary arteries to which they are anastomosed. Once the plaque and thrombi are dislodged from the vein, they can move downstream, completely blocking another portion of the coronary artery and causing myocardial infarction. In fact, coronary embolization as a complication of balloon angioplasty of saphenous vein grafts is higher than that in balloon angioplasty of native coronary arteries. Therefore, balloon angioplasty of vein grafts is performed with the realization that involvement by friable atherosclerosis is likely and that atheroembolization represents a significant risk.
Because of these complications and high recurrence rates, old diffusely diseased saphenous vein grafts have been considered contraindications for angioplasty and atherectomy, severely limiting the options for minimally invasive treatment. However, some diffusely diseased or occluded saphenous vein grafts may be associated with acute ischemic syndromes, necessitating some form of intervention.
Furthermore, attempts heretofore have been made to treat occlusions in the carotid arteries leading to the brain. However, such arteries have been very difficult to treat because of the possibility of dislodging plaque which can enter various arterial vessels of the brain and cause permanent brain damage. Attempts to treat such occlusions with balloon angioplasty have been very limited because of such dangers. In surgical treatments, such as endarterectomy, the carotid artery is slit and plaque is removed from the vessel in the slit area. Such surgical procedures have substantial risk associated with them which can lead to morbidity and mortality.
In other procedures, such as in angioplasty and in the treatment of peripheral arteries and veins, there is the possibility that the guide wires and catheters used in such procedures during deployment of the same may cause dislodgement of debris or emboli which can flow downstream and cause serious damage, such as stroke, if they occlude blood flow in smaller vessels. Moreover, when treating aneurysms, coils or other objects deployed to fill the aneurysm may break free and become lost downstream. Thus, in summary, embolization and migration of micro-emboli downstream to an end organ is a major concern of cardiologists during catheterizations.
Accordingly, what is needed is an exchange method for use during treatment of narrow blood vessels such as the carotid arteries, coronary arteries and saphenous vein grafts. Specifically, what is needed is a method which allows an exchange of catheters while a distal occluding device is deployed to perform treatment within the vessel and to contain emboli produced, created, or used during the treatment procedure. Furthermore, because a distal occluding device may block the flow of blood to vital organs, it is desirable that the exchange be performed quickly and easily in order to minimize the time that the blood vessel is occluded.
The present invention satisfies the above needs by providing a method for exchanging catheters during an emboli containment procedure. As described herein, the term xe2x80x9cembolixe2x80x9d may refer to any debris, particles, or other objects found, created or placed in a blood vessel. xe2x80x9cEmboli containmentxe2x80x9d may refer to emboli removal, neutralization, disintegration, minimization, or simply to preventing emboli from moving downstream. In essence, xe2x80x9ccontainmentxe2x80x9d refers to any procedure which reduces the deleterious effects that emboli may have on the patient. The preferred exchange method is particularly useful in angioplasty and similar procedures in smaller blood vessels such as the coronary or carotid arteries or in saphenous vein grafts. The exchange method described herein can be accomplished rapidly to minimize the time that a treated blood vessel is occluded for treatment.
For example, in most angioplasty procedures, a guidewire is first introduced into the vasculature of a patient until the distal end of the guidewire is near the occlusion or stenosis. The guidewire preferably bears a distal occlusion device, such as a balloon, filter, coil, or combination of these elements. The occlusive device is preferably activated prior to performing therapy to remove or reduce an occlusion or stenosis, to provide a working area and to prevent particles and debris produced during therapy from migrating downstream. The occlusive device may completely or partially occlude the vessel.
In order to perform an exchange over the guidewire catheter, the catheter must be made such that the occlusive device remains activated in order to minimize particles from going downstream. Furthermore, the proximal end of the guidewire must have a low profile to accommodate other catheters which are to be advanced over the guidewire. In one preferred method, a therapy catheter is advanced over a proximal end of the guidewire to the site of the plaque or lesion. After deploying the occlusive device on the end of the guidewire, therapy is performed on the lesion by the therapy device. One preferred therapy device is a dilatation catheter which compresses the lesion against the walls of the vasculature. In addition to dilatation balloon catheters, other forms of therapy may be used to dislodge, disintegrate, or neutralize the plaque. One method is to provide an ultrasonic catheter which targets the plaque and destroys it using shock waves. Another method is to use a vibration delivery catheter, which causes the plaque to break up due to a vibrating wire. Another method uses a drug delivery catheter provided over the guidewire, which provides fluids to dissolve the plaque. Other types of therapy include radiation therapy.
After treatment of the plaque by an appropriate therapy method, emboli often remain in the working area. The therapy catheter can then be removed and exchanged with an emboli removal catheter, such as an aspiration catheter for aspirating the emboli from the working area. The aspiration catheter can then be exchanged with another therapy catheter, such as a catheter bearing a stent which is deployed onto the lesion for maintaining the opening of the blood vessel.
The present invention in a preferred embodiment allows for the rapid and easy exchange of catheters by deploying the occlusive device in stages. For instance, when a guidewire with a distal occlusion balloon is used, the balloon is inflated only when there is danger of emboli moving downstream. Thus, if treatment of the stenosis consists of a dilatation procedure and deployment of a stent, the occlusion balloon will be inflated for a first inflation period during which the dilatation balloon works on the plaque, the dilatation catheter is exchanged with an aspiration catheter, and the aspiration catheter removes emboli from the vessel. After aspiration, the occlusion balloon can safely be deflated to allow blood flow for a period to organs downstream. An exchange can then be performed with another therapy catheter, such as a stent deploying catheter, and the occlusion balloon is reinflated for a second inflation period to deploy a stent to the location of the stenosis. By employing an exchange method with vessel occlusion occurring in stages, the time that blood flow is occluded in the vessel decreases, thereby minimizing the risks to the patient and presenting significant advantages over known technology. The speed of exchange is also improved by using an adaptor which allows for easy and quick handling of the guidewire for inflation and deflation.